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Nordic Luveris Study
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
Collaborators:
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00553293
First received: November 2, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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Purpose
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.
| Condition | Intervention | Phase |
|---|---|---|
| Infertility In Vitro Fertilization | Drug: recombinant luteinizing hormone (Luveris) Drug: recombinant follicle stimulating hormone (Gonal-f) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Hormones
Drug Information available for:
Lutropin alfa
U.S. FDA Resources
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Ongoing pregnancy rate per started stimulation cycle [ Time Frame: ultrasound showing ongoing pregnancy ]
Secondary Outcome Measures:
- Ongoing pregnancy in subgroups of patients with lo0w serum LH levels [ Time Frame: ultrasound for ongoing pregnancy in subgroups ]
| Enrollment: | 526 |
| Study Start Date: | August 2003 |
| Study Completion Date: | November 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A,1
rFSH + rLH arm
|
Drug: recombinant luteinizing hormone (Luveris)
75 iu/day form cycle day 6
Other Name: Luveris
|
|
Placebo Comparator: A,2
rFSH alone
|
Drug: recombinant follicle stimulating hormone (Gonal-f)
rFSH 150 iu/day
Other Name: Gonal-f
|
Eligibility| Ages Eligible for Study: | 21 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age below 40
- Infertility treatable by IVF or ICSI
- Regular cycles
Exclusion Criteria:
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553293
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553293
Locations
| Denmark | |
| Anders Nyboe Andersen | |
| Copenhagen, Denmark, 2100 | |
Sponsors and Collaborators
Rigshospitalet, Denmark
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Investigators
| Principal Investigator: | Anders N Andersen, professor | Fertility Clinic Rigshospitalet |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00553293 History of Changes |
| Other Study ID Numbers: |
KF02-035/03 |
| Study First Received: | November 2, 2007 |
| Last Updated: | November 2, 2007 |
Keywords provided by Rigshospitalet, Denmark:
|
infertility in vitro fertilization LH supplementation Benefits |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Hormones |
Follicle Stimulating Hormone Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017